Rapid Antidepressant Effects of ATP and Phosphocreatine

Major Depressive Disorder Clinical Trial

Official title:

A Preliminary Clinical Study on the Rapid Antidepressant Effects of Adenosine Triphosphate (ATP) and Phosphocreatine Combinated With Fluoxetine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03138681
• Other study ID #: 2017-SJNK-001
• Status: Recruiting
• Phase: Phase 2
• First received: April 24, 2017
• Last updated: May 3, 2017
• Start date: May 3, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: April 2017
• Source: Zhujiang Hospital
• Contact: Lianxu Zhao, M.D.
• Phone: 020-62783082
• Email: zhaolianxu[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a preliminary, double-blind clinical trail aimed to investigate whether the combination of fluoxetine with ATP or phosphocreatine has a rapid antidepressant effect. 42 patients with major depressive disorder (Hamilton Depression Rating Scale (HAMD) score >= 20) will be recruited and divided into 3 groups randomly. This study involves two periods. In the first period, one group will be treated with fluoxetine and placebo, one with fluoxetine and ATP, and one with fluoxetine and phosphocreatine for 2 weeks. Placebo, ATP and phosphocreatine will be given intravenously, and fluoxetine orally. In the second period, each patient will be only given fluoxetine for 4 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 year-old male or female

• Major depressive disorder diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

• Hamilton depression rating scale score >= 20 at screening

• Written informed consent

Exclusion Criteria:

• Participants of other clinical trials in recent 4 weeks

• Suicidal idea or action that requires hospitalization

• Post Traumatic Stress Syndrome in recent 6 months

• Secondary depression, or have a direct familial history of schizophrenia

• Diseases that prevent from appropriate expression of depressive emotion

• Psychiatric disorders including bipolar disorder and schizophrenia

• Severe heart, kidney, lung or liver diseases that require hospitalization

• Diabetes

• Neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor)

• Inflammatory disease including autoimmune disease

• Taking anti-inflammatory medication

• Taking antiarrhythmic drugs, antidiabetic agents or tryptophan

• Substance abuse or dependence history in recent 6 months

• Pregnant or having plan to be pregnant

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Placebo
placebo is given intravenously twice a day for 14 days
• ATP
ATP (100mg) is given intravenously twice a day for 14 days
• Phosphocreatine
Phosphocreatine (1g) is given intravenously twice a day for 14 days

Locations

Country	Name	City	State
China	Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Hamilton depression rating scale during the first six weeks		baseline, 1st, 2nd, 4th, 6th week
Secondary	Changes in Patient Health Questionnaire (PHQ-9) during the first six weeks		baseline, 1st, 2nd, 4th, 6th week
Secondary	Changes in Clinical global impression scale during the study		baseline, 2nd, 4th, 10th week
Secondary	Side effects assessment during the first six weeks		1st, 2nd, 4th, 6th week